Gilead Jumps After FDA Approves Its Kite-Acquired CAR-T Drug

A family in Massachusetts was hospitalized with carbon monoxide poisoning after they turned the heat on for the first time this season

Each treatment of the T-cell therapy is customized using a patient's own immune cells, starting with T cells collection via apheresis, shipment to a manufacturing facility, and genetic modification of the cells to express a auto specific to CD19, which is commonly over-expressed in B cell malignancies allowing the modified immune cell to target and kill the lymphoma cell.

Adults with relapsed or refractory non-Hodgkin lymphoma (NHL) now have new hope. The FDA cautions that the drug is not indicated to treat patients with primary central nervous system lymphoma. They are extracted, genetically engineered to recognize cancer cells, and infused back into the patient, where they form an army to attack and destroy malignant cells, potentially for years.

Gilead's chief executive John Milligan said the drug's FDA approval was an "important day" for lymphoma patients who had "limited" treatment options.

In a clinical trial of more than 100 adults, 51% of patients treated with Yescarta achieved complete remission, far higher than what is normal with present standard-of-care treatments.

The therapy includes a boxed warning for cytokine release syndrome and neurologic toxicities, the FDA said.

The treatment, called Yescarta, will cost $373,000 per patient, according to drugmaker Gilead Sciences.

The market capitalization of Gilead is now reeling at 104.65B based on its aggregate value over its current share price and the total amount of outstanding stocks.


The U.S. Food and Drug Administration (FDA) approved the chimeric antigen receptor T-cell (CAR-T) therapy, a new therapy for a type of lymphoma, developed by Gilead Science's acquired unit Kite Pharma.

"The acquisition of Kite establishes Gilead as a leader in cellular therapy and provides a foundation from which to drive continued innovation for people with advanced cancers", GILD CEO, John F. Milligan, Ph.D., said in a statement.

The therapy, Yescarta or axicabtagene ciloleucel, will be used on adult patients with certain types of large B-cell lymphoma after other treatments fail, CNN reported on Thursday.

All patients had chemorefractory disease and had received a median of 3 prior lines of therapy, with 54% refractory to 2 consecutive lines of therapy. "Many of the patients that received CAR-T therapy had already relapsed several times with traditional treatments such as chemotherapy or hematopoietic stem cell transplant". Other side effects include infections, low blood cell counts, and dampened immune system. Arie Belldegrun, MD, FACS, Founder of Kite, said in a statement.

Similar CAR-T therapies are being developed by Juno Therapeutics Inc., Bluebird Bio Inc., and others.

Dr. David Maloney, medical director of cellular immunotherapy at Fred Hutchinson Cancer Research Center, helped develop the therapy and said the FDA's second approval of a CAR-T cell therapy "validates the revolution underway in the field of cellular immunotherapy". The side effects can lead to high fevers and flu-like symptoms, and it can be life-threatening.

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